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Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans (ARMS-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350465
Recruitment Status : Recruiting
First Posted : January 29, 2015
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE January 19, 2015
First Posted Date  ICMJE January 29, 2015
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE March 1, 2015
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2015)
Change from Baseline in Sonographic Lean Body Mass at 3 months [ Time Frame: At study baseline for all subjects, and at Week 6 and 12 of the intervention period for subjects randomly assigned to an exercise group ]
US estimates of aggregate regional LBM (muscle thickness, cm), will be assessed using B-mode diagnostic US with a 13-6 megahertz (MHz) linear array transducer for morphology measures at 6 axial and appendicular sites.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
  • Change from Baseline in dual-energy X-ray absorptiometry (DXA) scanning at 3 months [ Time Frame: At study baseline for all subjects, and at Week 12 of the intervention period for subjects randomly assigned to an exercise group ]
    Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF).
  • Change from Baseline in metabolic status at 3 months [ Time Frame: At study baseline for all subjects ]
    A blood sample (60 cc) will be obtained after an 8-hour overnight fast: glucose and insulin levels will be assessed. Other laboratory values will be obtained such as a standard lipid profile and glycated hemoglobin (HbA1C).
  • Change from Baseline in intramuscular adipose tissue assessment at 3 months [ Time Frame: At study baseline for all subjects ]
    Estimates of intramuscular adipose tissue (IMAT) will be obtained with magnetic resonance imaging using a whole body transmit/receive coil for T2 fat image acquisition of the thigh (dominant side) will be obtained at the mid-femur region.
  • Change from Baseline in strength assessment at 3 months [ Time Frame: At study baseline for all subjects, and at Week 6 and 12 of the intervention period for subjects randomly assigned to an exercise group ]
    Grip strength will be assessed bilaterally; isometric and isokinetic knee extension/flexion torques will be obtained bilaterally using a dynamometer. Peak concentric torque (at 60 /s and 180 /s) will be obtained in a randomized fashion with subject positioning and stabilization per the manufacturer operations manual.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2015)
  • Change from Baseline in dual-energy X-ray absorptiometry (DXA) scanning at 3 months [ Time Frame: At study baseline for all subjects, and at Week 12 of the intervention period for subjects randomly assigned to an exercise group ]
    Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF).
  • Change from Baseline in metabolic status at 3 months [ Time Frame: At study baseline for all subjects ]
    A blood sample (60 cc) will be obtained after an 8-hour overnight fast: glucose and insulin levels will be assessed before and during a standard (75 g) 2 hour oral glucose tolerance test (to determine insulin sensitivity via the homeostasis model assessment (HOMA) insulin resistance algorithm. Other laboratory values such as a standard lipid profile and glycated hemoglobin (HbAC1).
  • Change from Baseline in intramuscular adipose tissue assessment at 3 months [ Time Frame: At study baseline for all subjects ]
    Estimates of intramuscular adipose tissue (IMAT) will be obtained with magnetic resonance imaging using a whole body transmit/receive coil for T2 fat image acquisition of the thigh (dominant side) will be obtained at the mid-femur region.
  • Change from Baseline in strength assessment at 3 months [ Time Frame: At study baseline for all subjects, and at Week 6 and 12 of the intervention period for subjects randomly assigned to an exercise group ]
    Grip strength will be assessed bilaterally; isometric and isokinetic knee extension/flexion torques will be obtained bilaterally using a dynamometer. Peak concentric torque (at 60º/s and 180º/s) will be obtained in a randomized fashion with subject positioning and stabilization per the manufacturer operations manual.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans
Official Title  ICMJE Detection and Treatment of Sarcopenia and Myosteatosis in Older African Americans
Brief Summary The objectives of this study are to: 1) validate a rapid, portable, cost-effective method for screening myosteatosis and sarcopenia using diagnostic ultrasound, and 2) investigate a novel approach to progressive resistance exercise involving eccentric muscle actions that will counter the local effects of myosteatosis and sarcopenia in African Americans.
Detailed Description The rationale for this study is the need to proactively address health disparities associated with age-related skeletal muscle dysfunction. Age-related changes in muscle may be characterized by sarcopenia (i.e., loss of muscle mass) and/or myosteatosis (i.e., excessive intramuscular adipose tissue). These changes may result in physical impairments that may be exacerbated by the lack of a formal screening and diagnosis process for older adults in standard healthcare settings. Myosteatosis may compound the effects of sarcopenia and play a significant role the age-related functional decline and higher incidence of type 2 diabetes observed in African Americans in comparison to other ethnic/racial groups. The initial phase of the study will involve the assessment of older African Americans (n = 70) to characterize muscle size and quality in comparison to a younger reference group (n = 70). Participants randomly selected from the older subject pool will be assigned to either the Eccentric Exercise Group or the Concentric Exercise Group for 12 weeks of a supervised strengthening exercise regimen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcopenia
Intervention  ICMJE
  • Behavioral: Eccentric Exercise
    Submaximal progressive resistance exercise (PRE) using eccentric muscle actions for the knee extensors/flexors will be performed for 10 repetitions, 3 to 4 sets, twice per week for 12 weeks.
    Other Name: Negative work training
  • Behavioral: Concentric Exercise
    Submaximal progressive resistance exercise (PRE) using concentric muscle actions for the knee extensors/flexors will be performed for 10 repetitions, 3 to 4 sets, twice per week for 12 weeks.
    Other Name: Conventional strength training
Study Arms  ICMJE
  • Experimental: Eccentric Exercise
    Supervised strengthening exercise using eccentric muscle actions.
    Intervention: Behavioral: Eccentric Exercise
  • Active Comparator: Concentric Exercise
    Supervised strengthening exercise using concentric muscle actions.
    Intervention: Behavioral: Concentric Exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2015)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • An African American adult.
  • Between 18 and 30 years of age, or between 65 and 85 years of age.
  • Able to independently walk at home and in your community (use of an assistive device like a cane or a walker is acceptable).

Exclusion Criteria:

  • Uncontrolled hypertension or other cardiovascular disease.
  • A Body Mass Index of 32.5 or above may be an exclusion criterion if the X-ray technician determines that dimensions of the scanning bed are not adequate for a reliable examination.
  • A musculoskeletal condition that would stop you from performing the physical assessment tests.
  • Muscle weakness due to neurological disease or injury (such as stroke or spinal cord injury).
  • Moderate to severe sepsis (blood infection) or edema (such as swelling of a limb).
  • Been hospitalized over the last three months.
  • History of a broken arm or leg bone because of osteoporosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michael Harris-Love, DSc MPT BS (720) 857-2802 Michael.Harris-Love@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02350465
Other Study ID Numbers  ICMJE E1854-W
MIRB01714 ( Other Identifier: Washington D.C. Veterans Affairs Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Harris-Love, DSc MPT BS Rocky Mountain Regional VA Medical Center, Aurora, CO
PRS Account VA Office of Research and Development
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP